U.S. patent number 5,824,216 [Application Number 08/650,929] was granted by the patent office on 1998-10-20 for blood collection container.
This patent grant is currently assigned to Baxter International Inc.. Invention is credited to Jean-Claude Bernes, Jack Debrauwere, Richard Goldhaber, Michel Joie.
United States Patent |
5,824,216 |
Joie , et al. |
October 20, 1998 |
Blood collection container
Abstract
A container for housing body fluids, preferably blood in its
component form. The container comprises a body defined by flexible
walls having an interior for housing the body fluid. Additionally,
a means for allowing selective fluid flow allows the blood
components to be expressed from one chamber of the container into
another to separate and separately house the blood components. The
present invention also provides a method for separating blood into
its components and individually storing same.
Inventors: |
Joie; Michel (Ernage,
BE), Debrauwere; Jack (Halle, BE), Bernes;
Jean-Claude (Faimes, BE), Goldhaber; Richard
(Lake Forest, IL) |
Assignee: |
Baxter International Inc.
(Deerfield, IL)
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Family
ID: |
22909167 |
Appl.
No.: |
08/650,929 |
Filed: |
May 17, 1996 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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241080 |
May 11, 1994 |
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Current U.S.
Class: |
210/257.1;
210/252; 604/410; 604/408; 604/403 |
Current CPC
Class: |
B01D
21/34 (20130101); B01D 21/26 (20130101); B01D
21/262 (20130101); B01D 21/245 (20130101); B01D
21/0003 (20130101); A61M 1/029 (20130101); A61M
1/0209 (20130101); B01D 21/2433 (20130101); A61M
2205/6072 (20130101); B01D 2221/08 (20130101); A61J
1/10 (20130101); B01D 2221/10 (20130101) |
Current International
Class: |
B01D
21/26 (20060101); A61M 1/02 (20060101); B01D
21/00 (20060101); A61J 1/00 (20060101); A61M
001/00 (); B65D 030/22 () |
Field of
Search: |
;210/257.1,252
;604/403,404,408,409,410,415 ;383/37 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Kim; John
Attorney, Agent or Firm: Barrett; Robert M. Rockwell; Amy L.
H. Price; Bradford R. L.
Parent Case Text
This appication is a continuation of U.S. patent application Ser.
No. 08/241,080, filed May 11, 1994, now abandoned.
Claims
We claim:
1. A container for housing blood products comprising:
an integral body defined by flexible walls defining at least a
first, a second and a third chamber, the chambers linearly arranged
in a horizontal row with the first chamber adjoining the second
chamber and the second chamber adjoining the third chamber, each
chamber having a linear exterior edge wherein the linear exterior
edge of the first chamber adjoins the linear exterior edge of the
second chamber and the linear exterior edge of the second chamber
adjoins the linear exterior edge of the third chamber forming a
linear side and further wherein a connection site and an exterior
port are located on each of the exterior edges; and
means for allowing selective fluid communication between a first
chamber and a second chamber and between a second chamber and a
third chamber.
2. The container of claim 1 wherein the means for allowing
selective fluid communication is a frangible access port.
3. The container of claim 1 wherein the body is constructed from
plastic.
4. The container of claim 1 wherein the body includes apertures for
securing the body on blood processing equipment.
5. The container of claim 1 wherein the body includes a flexible
edge between each chamber constructed so that the chambers can be
folded upon each other at the chamber edge.
6. The container of claim 1 further comprising a means for labeling
the container wherein each chamber bears similar indicia.
7. The container of claim 6 wherein said means for labeling is a
bar code.
8. The container of claim 1 wherein one of the chambers further
comprises a wall member for defining at least one channel in fluid
communication with the chamber.
9. The container of claim 8 wherein the channel is located in a
portion of the container that includes a label on one of the
flexible walls that defines the portion.
10. The container of claim 9 wherein the label is a bar code.
11. The container of claim 9 wherein the label is a peelable
sticker.
12. A container for housing blood comprising:
an integral body defining at least two interior chambers for
housing blood, each chamber having an exterior edge formed along
one side of each of the chambers forming a continuous edge of the
body and a common edge wherein the chambers are joined at the
common edge and further wherein each of the at least two interior
chambers includes a connection site and an exterior port located on
the exterior edge;
a port located through the common edge of the at least two
chambers, the port including a frangible member in the port that
upon breakage allows fluid flow from one of the at least two
chambers of the body to another one of the at least two chambers;
and
a tube allowing blood to be received in one of the at least two
chambers.
13. The container of claim 12 wherein the body is constructed from
plastic.
14. The container of claim 12 wherein the body is constructed from
a polyvinyl chloride-containing material.
15. The container of claim 12 wherein the body includes three
chambers.
Description
BACKGROUND OF THE INVENTION
The present invention generally relates to the storage of body
fluids. More specifically, the present invention relates to the
separation of blood into its components and the storage of blood
components.
It is, of course, known to use blood and other body fluids in a
number of medical procedures. Blood transfusions are an example of
such procedures. Blood is collected from a donor and can be
transfused into a recipient.
Blood after being received from a donor is stored, typically, in
flexible plastic containers until use. Blood can either be stored
in a container as whole blood or broken down into its individual
components, (i.e., plasma, buffy coat layer, and packed red cells).
For example, it is known to separate whole blood either through a
centrifuge process, or a process such as that disclosed in U.S.
Pat. Nos. 4,350,585 and 4,608,178, into plasma, buffy coat, and
packed red cells.
In a great majority of cases, blood is stored for a number of days
and not immediately infused into a recipient. In most situations,
the blood components are separately stored. For example, it is
known to separately store and utilize the red blood cell component
of whole blood.
In order to maintain the viability of red blood cells and other
blood components, it is necessary to provide a storage solution to
provide an energy source for the red blood cells.
Previous systems of manual blood collection consist of several
blood packs connected with pieces of tubing and isolated, if
necessary, by frangible parts. Most of the prior art pack
configurations have a similar construction with a collection bag
filled with anti-coagulant solution wherein, e. g., one pack is
dedicated to the storage of red blood cell concentrates mixed with
the preservative solution and one transfer pack is dedicated to the
processing and storage of plasma.
In a known system, marketed by Baxter International under the
trademarks OPTIPRESS.RTM. and OPTIPAC.RTM., whole blood is
collected. The whole blood is then centrifuged to separate the
blood into plasma, red blood cells, and a buffy coat. Plasma and
red blood cells are separated by being removed from the blood pack
through top and bottom tubes connected to peripheral transfer
packs.
Although, the use of a triple pack configuration provides a system
that can store blood components, a typical triple blood pack can
present some issues. For example, the handling of a triple blood
pack can be cumbersome due to the tubing becoming knotted and
intertwined. Further, the pieces of tubing in the triple packs are
labor intensive to manufacture and can create problems with bonding
and kinking during sterilization. Furthermore, the packaging of
triple packs with attached tubing can be problematic.
There therefore may be a need for an improved system for collecting
and storing blood and its components.
SUMMARY OF THE INVENTION
The present invention provides an improved blood collection system.
To this end, a single container is provided for separately housing
blood components. The container includes a body defined by flexible
walls defining at least a first, a second and a third chamber.
Means are provided for allowing selective fluid communication
between the first chamber and the second chamber and between the
second chamber and the third chamber. The container of the present
invention provides a compact tubeless system for collecting and
separately storing blood components.
In use, blood can be collected in the middle or second chamber of
the container. The container is then centrifuged to separate the
blood into a plasma layer, a red blood cell layer, and a buffy coat
layer. The upper layer will be the plasma layer, the middle layer
the buffy coat layer and the lower layer the red blood cell layer.
Pursuant to the present invention, the frangible connections
located in the tubes between the first and second chamber and
second and third chamber, can be separated and the bottom layer
expressed into the first chamber and the top layer expressed into
the third chamber.
In an embodiment, a blood separator is used to express the blood
into the different chamber.
In an embodiment, the chambers are sealed by heat sealing the tubes
after the blood components are expressed into appropriate
chambers.
In an embodiment, the blood collection system has bar code labeling
for identification.
In an embodiment, the present invention provides a blood separation
apparatus having a means for sensing levels of blood and its
components. In an embodiment, the blood separation apparatus has an
optical sensor.
In an embodiment, the container has a plurality of mounting holes
for securing the container to the blood separation apparatus.
An advantage of the present invention is that it provides an
improved container for housing blood components.
Another advantage of the present invention is that it provides a
blood collection system that reduces the manufacturing costs by
providing the capability for high volume, highly automated
production.
Moreover, an advantage of the present invention is that it provides
an improved method for storing blood components.
Further, an advantage of the present invention is that it provides
a blood collection system having improved handling
characteristics.
Still further, an advantage of the present invention is that it
provides a blood collection system that does not include a
plurality of tubing.
Another advantage of the present invention is that it provides
several channels of separated blood for later analysis. Moreover,
an advantage of the present invention is that it provides a blood
collection system with improved labeling features for better
traceability and safety.
Another advantage of the present invention is to provide an
apparatus for improved blood separation.
Additional features and advantages of the present invention are
described in, and will be apparent from, the detailed description
of the presently preferred embodiments and from the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a perspective view of a container of the present
invention.
FIG. 2 illustrates the container of the present invention of FIG. 1
in a preferred folded orientation in preparation for
centrifugation.
FIG. 3 illustrates an embodiment of the container of the present
invention mounted in a blood separation system.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS
The present invention provides an apparatus and method for
separating and storing blood components in separate chambers. As
used herein, the term "blood" includes whole blood as well as its
components including, but not limited to, red blood cells, plasma,
platelets, and leukocytes (i.e., buffy coat).
Pursuant to the present invention, an integral container is
provided for collecting, separating, and storing blood components.
Referring now to the figures, FIG. 1 illustrates the blood
collection system of the present invention. Preferably the
container includes a body made of flexible material (i.e., PVC or
other suitable material). The body is divided into multiple
chambers that can house blood and separately store the blood
components in the individual chambers. The chambers are also
isolated by frangible access ports.
Referring specifically to an embodiment illustrated in FIG. 1, a
container 10 having a body 12 is preferably constructed from
flexible sheets of plastic. The sheets are sealed along their edges
14 to create an interior 15. The container 10 is divided into three
chambers, namely, a first chamber 17, a second chamber 18 and a
third chamber 19.
A number of plastics can be utilized. Depending on the specific
components to be stored, certain plastics may be more desirable. In
an embodiment, the container is constructed from a polyvinyl
chloride material that is plasticized and includes stabilizers. The
container material is preferably flexible to facilitate folding the
container for storage. To this end, a fold line 13 is provided
between each chamber of the container to facilitate folding the
container for centrifuging and other processing while the blood is
stored in the container.
Each chamber of the container 10 preferably includes at least one
port that provides access to the interior 15 of the individual
chambers. For example, a donor tube 20 is provided, through which
blood can be collected into the second chamber 18 of the container.
In the preferred embodiment illustrated, sterile connections sites
22 and administration ports 21 are also provided on each chamber of
the container.
In order to provide means for allowing the blood components to be
stored in separate compartments, at least two tube members are
provided. A first tube member 28 being located between the first
and second chambers 17 and 18, respectively, and a tube 29 being
located between the second and third chambers 18 and 19,
respectively. In order to provide selective fluid flow between the
chambers, a frangible cannula 30 and 31 is located in each of the
tubes 28 and 29, respectively. By breaking the appropriate
frangible cannula, fluid flow between the chambers can be
established. Of course, other means of establishing selective fluid
communication can be used.
In the illustrated embodiment, another feature provided on each
chamber of the container and illustrated in FIG. 1 is means
(mounting holes) for securing the container 10 to a blood separator
50 (discussed below). In the illustrated embodiment, the mounting
holes 41 are located approximately at the outer edges of the first
chamber 17 and the third chamber 19. Additionally, the center
chamber 18 has two sets of mounting holes 41. The mounting holes 41
are used to align the container 10 on a blood separator 50
(discussed below).
Another illustrated feature of the container is a set of segments
sealing lines 40. These are located, for example, on the edge of
the first chamber 17 and can be used for providing cross-matching
segments. In addition to providing cross-matching segments, which
aid in the identification of the blood components, the present
invention advantageously provides a further identification feature,
namely a donation number identifying each chamber with a bar code
61 or a number printed on the pack during manufacturing. This bar
code 61 provides that the three individual packs are identifiably
correlated.
Also illustrated in FIG. 1 are peelable stickers 62 with
corresponding donation numbers. These stickers 62 provide labeling
for the individual chambers that house the blood components and can
be printed and affixed to the chambers during the manufacturing of
the container. The peelable stickers 62 also provide that the three
individual packs are identifiably correlated, i.e. as being from
the same source. Also, the peelable stickers 62 provide for other
specialized labeling functions as desired. For example, these
stickers 62 provide labeling for later use on test tubes containing
the donor's blood samples.
Many of the features of the preferred embodiments listed above
improve and facilitate a primary purpose of the present invention,
to wit, the collection, separation and storage of blood. In a
preferred embodiment of the present invention, the blood is
collected from the patient and enters the center or second chamber
18 of the three-chambered pack 10. To accomplish this, the donor
tube 20 extends either from a donor needle or from another
container containing blood. Blood then flows through the donor tube
20 into the interior 15 of the container 10. Each of the chambers
is provided with an administration port 21 and a sterile connection
site 22 to process the contents of the component packs by usual
blood bank procedures (i.e., red cell filtration on SAG-M pack,
buffy coat pooling and single donor platelet by a known PRP
method). After donation is completed, the donor tube 20 is stripped
and sealed to provide cross-matching segments, if necessary.
Also, after the blood has been added to the container 10 pursuant
to the invention, the donor tube 20 can be severed from the
container 10. A variety of methods can be used to so sever the
donor tube 20 including using a heat sealer. The donor tube 20 can
then be used for cross-matching purposes.
After collecting the blood, further processing can be performed,
i.e., centrifugation for separating the blood into its components.
To this end, the pack is folded as shown in FIG. 2 in preparation
for centrifugation. First, the first chamber 17 is laid flat. Then
the second chamber 18 is folded upon it along the fold line 13
between the adjacent first and second chambers. Finally, the third
chamber 19 is similarly folded upon the second chamber 18 along the
fold line 13 between the adjacent second and third chambers. The
folded pack provides a clean, efficient package for easily handling
the collected blood; no excessive tubing is present to become
tangled. The folded pack is then placed in a centrifuge bucket for
spinning with the sterile connection sites 22 and administrative
ports 21 placed on the side of the assembly.
The centrifuge separates the collected whole blood into its
components (i.e., plasma, buffy coat layer and packed red cells).
The separated layers are all contained within the second chamber 18
after centrifugation; the components are stratified. The packed red
cells reside nearest the fold line 13 at the junction of the first
chamber 17 and the second chamber 18. The plasma resides nearest
the fold line 13 at the junction of the second chamber 18 and the
third chamber 19. The buffy coat is disposed between the red cells
and plasma in the second chamber 18.
After centrifugation to separate the three components of the
donated blood (i.e., plasma, buffy coat layer, and packed red
cells), the collection system is carefully unfolded and secured to
a blood component separator. The blood component separator
preferably operates in a manner similar to that used in a press
sold by affiliates of Baxter International under the trademark
OPTIPRESS.RTM..
FIG. 3 is an embodiment of the invention illustrating a blood
component separator apparatus 50 that can be used for separating
whole blood into plasma, red blood cells, and buffy coat.
A preferred embodiment illustrated in FIG. 3 provides an automated
blood component separator 50. The separator 50 has a front face 55
and a control panel 56. The operator uses this panel 56 to operate
the blood component separator 50 in an automated manner. Thus,
after the blood component separator 50 has been activated, the
operator may leave the automated separator 50 unattended to
separate the collected whole blood into its components. To
accomplish this, the container 10 is secured to the front face 55
of the blood component separator 50 by using mounting pegs 52 which
cooperate with the alignment mounting holes 41 on the container 10.
Also shown in FIG. 3 near the base of the separator 50 is a segment
sealing bar 51, which aids in holding the container 10 to the blood
component separator 50.
Further elements of the blood component separator 50 include a
frangible opening, sealing and cutting bar 54. This bar 54 is
located at the folding seam 13 between the first chamber 17 and the
second chamber 18, approximately a third of the way up the front
face 55. Similarly, at the folding seam 13 between the second
chamber 18 and the third chamber 19 is another similar bar 54. In
addition, the frangible opening, sealing and cutting bar 54 has
tools for accomplishing several tasks. For example, the bar 54 has
a tool for opening the frangible cannula 30 to provide fluid
communication between the adjacent chambers. These bars 54 also aid
in holding the container 10.
In the preferred embodiment illustrated, in order to provide
selective fluid communication between the interior 15 of one
chamber and the interior 15 of another chamber of the container 10,
a frangible cannula 30 is utilized. To provide fluid communication,
the frangible cannula 30 is biased so that a portion thereof breaks
away from the remaining portions of the cannula. This allows the
fluid within one chamber to flow into the interior of an adjacent
chamber of the container, for example, from the second chamber 18
to the first chamber 17. Although in the embodiment illustrated, a
frangible cannula 30 is used, any means for allowing selective
access between the interiors of the container can be utilized.
To this end, the frangible opening, sealing and cutting bars 54
located at the top and bottom of the center or second chamber 18
have tools designed to open the frangible cannula 30, 31 to allow
fluid flow between the peripheral chambers. By using the frangible
opening bar 54 to open the frangible cannula 30, fluid
communication between, for example, the first chamber 17 and the
second chamber 18 can occur.
With the centrifuged container 10, having the stratified layers of
blood components (i.e., an upper layer of blood plasma, a center
layer of buffy coat and a lower layer of red blood cells) in the
center or second chamber 18, secured to the blood separator 50, the
separation of the components into separate chambers may begin. The
bars 54 open the cannula 30 and 31 to allow fluid communication
from the second chamber 18 to the first chamber 17 and from the
second chamber 18 to the third chamber 19, respectively.
The blood separator 50 is provided with appropriate means for
expressing the upper plasma layer from the center or second chamber
18 through the upper cannula 31 to the empty upper or third chamber
19. Similarly, the blood separator 50 is provided with appropriate
means for expressing the lower red blood cell layer from the center
or second chamber 18 through the lower cannula 30 to the lower or
first chamber 17. The first chamber 17 is prefilled with a
preservative solution to permit extended storage of the red blood
cells.
The top and bottom flows are controlled by clamps (not shown). The
clamps are monitored with the optical monitoring device 53
illustrated in FIG. 3. The optical monitoring device 53 detects the
levels of the blood components in the chambers. This device detects
when substantially all the red blood cells have been expressed from
the second chamber 18 to the first chamber 17. The optical
monitoring device 53 thus activates the clamps to prevent further
fluid flow. In addition, the flow of plasma from the second chamber
18 to the third chamber 19 is expressed and stopped in a similar
fashion. In this embodiment, only the appropriate blood components
are expressed to the appropriate peripheral chambers. As a result
of the expressing of the blood components, the second chamber 18
subsequently contains only the buffy coat layer. Thus, after the
completed separation, the plasma is in the third chamber 19, the
buffy coat is in the collection bag; i.e., the second chamber 18
and the red blood cells are in the first chamber 17.
To this end, after the blood components transfer is completed, the
top and bottom transfer channels (i.e., the tubes 28 and 29) are
sealed by tools located in the same sealing and cutting bars 54.
This prevents further fluid communication between the chambers.
The first and second chambers and the second and third chambers are
then separated by cutting them away with a knife integrated into
the sealing and cutting bars 54 or by tearing them by hand using a
pre-notched folding line 13. Thus, after separation, each chamber
becomes an independent pack. The three separate chambers can then
be distributed to where they are needed or stored individually
until required.
As shown in FIG. 1, and briefly discussed above, the container 10
has labeling on each of the chambers. In a preferred embodiment,
the label is a bar code 61. The bar code is generated so that
information for identifying the source of the blood is readily
available. Also, for tracking and safety concerns, the bar code 61
on each individual chamber pack is correlated. Thus, if one chamber
pack is found to be unusable for any reason, the other two separate
chamber packs can be located simply by examining the corresponding
bar code and recalling the suspect chamber packs for inspection.
This benefit is especially advantageous because of its simplicity.
For instance, the bar code can be printed on the three chambers
individually while they are being manufactured and remain a part of
a single, integral container. Thus, the possibility of human error
involved in applying separate labels to these individual separated
packs, as is done in present practice, is virtually nullified.
In a further embodiment, an additional processing step may be
performed to aid in identification of the blood. The pre-notched
cross-matching segments 40 shown on the first chamber 17 can be
sealed by the segment sealing bar 51. Cross-matching segments 40
can also be integrated in the pack design by isolating channels in
the first chamber 17, the SAG-M pack, for example as shown in FIG.
1. The channels in the first chamber 17 are arranged parallel to
each other at the outer edge. Also, the cross-matching segments 40
are pre-notched. Further, they could be isolated by using a tube
sealer or by adding a sealing segment step on the component
separator. The channels could also have bar codes for
identification purposes.
Now referring again to FIG. 3 with the container 10 held on the
blood component separator 50, the cross-matching segments 50 are
disposed near the bottom of the front face 55. Three segments
sealing bars 51 mounted to the front face 55 are disposed directly
above and perpendicular to the channels of the cross-matching
segments 40. If desired, the segments sealing bar 51 is used to
seal the pre-notched segments 40. Then, the sealed segments are cut
or torn apart along the notch lines. In this manner, segments are
created for cross-matching.
It should be understood that various changes and modifications to
the presently preferred embodiments described herein will be
apparent to those skilled in the art. Such changes and
modifications can be made without departing from the spirit and
scope of the present invention and without diminishing its
attendant advantages. It is therefore intended that such changes
and modifications be covered by the appended claims.
* * * * *